(29 days)
Not Found
No
The summary describes cell cultures used for viral isolation and identification, with no mention of AI or ML technologies.
No
The device is composed of cell cultures used for the isolation and identification of viruses from clinical samples, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device, FreshCells™, is used to culture viruses and Chlamydia from clinical samples, which aids in the identification of these pathogens responsible for various diseases. This process of identifying disease-causing agents from clinical samples is a diagnostic function.
No
The device description clearly states that the device provides cell lines as nearly confluent monolayers, which are physical biological materials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the cell cultures are "to be used as hosts for the isolation and identification of specific viruses" from "clinical samples." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The device provides cell lines as "nearly confluent monolayers ready for use upon receipt." These are the biological reagents used in the diagnostic process.
- Performance Studies: The summary of performance studies mentions "virus susceptibility," which is a key performance characteristic for a diagnostic device used for virus isolation.
The device is a critical component in the process of isolating and identifying viruses from clinical samples, which is a diagnostic procedure performed outside of the human body.
N/A
Intended Use / Indications for Use
Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|---|---|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV. |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV. |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups. |
| MvlLu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco-epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps. |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV. |
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
Product codes (comma separated list FDA assigned to the subject device)
KIR
Device Description
The subject device provides HEL, HFF, LLC-MK2, MVILu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical tests consist of those used to characterize the product as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
0
510 (k) Summary
SEP 2 5 ga-
- Diagnostic Hybrids, Inc. a.1. 1 President Street Athens, OH 45701 (614)593-1784 FAX: (614) 593-0980 Attn: J.L. Brown Date of Preparation: June 10, 1997
- Trade Name: FreshCells™ a.2. Classification Name: Cells, Animal and Human, Cultured.
- A predicate device is that of BioWhittaker, marketed as cell cultures, a.3. Appendix II, pp. A-11 to A-13 of this 510(k) Notification.
- The subject device provides HEL, HFF, LLC-MK2, MVILu, NCI H292, Vero and a.4. WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period. after
- Cell cultures to be used as hosts for the isolation and a.5. Intended Use: identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|---|---|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV, |
| Poliovirus, Rhinovirus, Vesicular stomatitis | |
| (Indiana Strain) virus and VZV. | |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps, |
| Poliovirus, Rhinovirus, VZV. | |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus, |
| Myxovirus and Poxvirus groups. | |
| MvlLu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco- | |
| epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK |
| polyomavirus, Reoviruses, Measles virus, | |
| RSV, some strains of Influenza type A, most | |
| Enteroviruses and Rhinoviruses, Parainfluenza | |
| and Mumps. | |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles, |
| Mumps, Poliovirus type 3, Rotavirus, Rubella | |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV, |
| Influenza, Mumps, Poliovirus, Rhinovirus, | |
| RSV, VZV. |
1
a.6. A comparison of Technological Characteristics:
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Source of Cell Line. | ATCC or another approved supplier. | Same as predicate device. |
| Provided as nearly con- | ||
| fluent monolayers. | Cells are provided | |
| routinely as nearly | ||
| confluent monolayers. | Same as predicate device. | |
| Intended Use. | Isolation & Confirmation | |
| of specific viruses. | Same as predicate device. |
- The non-clinical tests consist of those used to characterize the product b.l. rne non as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
Not applicable. b.2.
b.3. Not applicable.
2
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
James L. Brown Vice President Product Development and · Regulatory Affairs Diagnostic Hybrids, Inc. One President Street Athens, Ohio 45701
SEP 2 5 1997
Re: K973212 Trade Name: Fresh Cells™ WI-38 Regulatory Class: I Product Code: KIR Dated: August 22, 1997 Received: August 27, 1997
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in-vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
FreshCella™ in Multiwell Plates, Shell Vials and Tubes. Device Name:
FreshCells™ are indicated for use in the isolation of Indications for Use: various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has Culture of viruses in specific cell lines has become even more important. become the standard for the identification of these viruses.
Pa
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
Prescription Use I (Per 21 CFR 801.109)
Over-The-Counter Use_
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